The Japanese Patent Office has issued a Decision to Grant a patent covering Absorption Systems' In Vitro Dissolution Absorption System (IDAS2).
IDAS2 is a unique test system that enables the simultaneous evaluation of drug dissolution and absorption in various dosage forms, including tablets, capsules, and pre-formulations.
Demand for testing dissolution and absorption with IDAS2 is high and continues to rise, due to its innovative design and its ability to predict in vivo pharmacokinetic product performance based on bench-top testing.
The primary claim in the patent application is a device for assessing drug dissolution, absorption and permeation, comprising a reservoir (for dissolution) with fluid bathing a permeability barrier composed of living human intestinal cells.
Using IDAS2, pharmaceutical scientists can rapidly evaluate two fundamental properties of a finished drug product (tablet, capsule, etc.) simultaneously:
The rate of dissolution, which is determined by the formulation and/or the manufacturing process used to incorporate the active pharmaceutical ingredient (API) into a solid dosage form; and
The rate of permeation of the dissolved drug substance across a human intestinal cell monolayer, which is an intrinsic property of the API.
Although, historically, permeability and dissolution have been measured independently, and usually under conditions that bear little resemblance to the in vivo situation, IDAS2 makes it possible to evaluate these two fundamental drug properties at the same time. The ability of IDAS2 to capture the interconnectivity between these processes, under experimental conditions that resemble the intestinal environment, has led to more accurate predictions of the way drugs behave in vivo.
The FDA’s implementation of the Biopharmaceutics Classification System (BCS), allowing biowaivers of in vivo bioequivalence (BE) studies for BCS Class 1 and BCS Class 3 APIs, has resulted in improved access to good-quality, affordable generic drugs.
However, BCS Class 2 and Class 4 APIs are not eligible for biowaivers and must be evaluated in vivo; for drug substances in these classes, IDAS2 could be particularly impactful in the development and/or selection of formulations with a higher probability of success in clinical BE studies.
Thus, the availability of IDAS2 for use in product development will have an immediate impact on development timelines and costs.
Absorption Systems chief scientist Dr. Ismael Hidalgoand technology co-inventor Dr Jibin said: “This latest milestone is the result of several years of hard work by our team of R&D scientists. We believe that IDAS2 will be extremely valuable in the pursuit of our goal of helping to get more effective and safer drugs to patients throughout the world sooner.”
Source: Company Press Release.